The purpose of this study is to determine whether Trichuris Suis Ova (TSO) is safe and effective in treating adults with autism spectrum disorder

Detailed Description

Autism is a pervasive developmental disorder affecting social, communicative, and compulsive/repetitive behaviors. It is also frequently accompanied by aggression, self-injury, and irritability, making care for these individuals a significant challenge for families or institutional settings. Currently risperidone is the only medication approved by the Food and Drug Administration (FDA) for irritability associated with autism, although not all patients respond to risperidone or are able to tolerate its side effects. As such, additional targeted treatments need to be explored in autism. Neuroimmune disturbance has been demonstrated in patients with autism (Ashwood et al., 2006; DelGuidice, 2003) and the presence of neuroinflammation may play a role in initiating or maintaining CNS dysfunction characteristic of the disorder (Pardo et al, 2005). Therefore, there is considerable interest in using immunomodulatory medications to address core and associated symptoms.

To date, many medications have been used in individuals with autism and the history of psychopharmacology of autism is notable for the exaggerated benefit of a variety of treatments. To date, most medication studies in the field have been open-label without use of a placebo control and without systematic behavioral assessments. The current practice of prescribing medications to patients with autism without scientifically demonstrated efficacy underscores the necessity for methodologically rigorous studies to be conducted.

We propose a double blind placebo-controlled crossover trial of TSO, where subjects would be randomized to receive placebo or TSO for 12 weeks, with a 4 week washout and then 12 weeks of the the treatment not yet received. To assess the effect on social cognition, repetitive behaviors, aggression and irritability, and global functioning in adults with autism spectrum disorder. The objectives of the proposed study are to develop an innovative treatment approach to autism by 1) assessing the safety and efficacy of TSO treatment using behavioral and laboratory outcome measures; 2) determining whether this treatment has sufficient promise to warrant consideration of a larger, multi-centered, placebo-controlled clinical trial; 3) conducting secondary analyses to explore the relationship between clinical features, immune mechanisms, and treatment response.

TSO will be administered in vials prepared by Coronado Biosciences. Vials will be diluted with a commercial drink and given to subjects to ingest. Subjects will receive a dose of 2500 ova every two weeks for 12 weeks.

Study Arm (s)

Experimental: Trichuris Suis Ova (TSO)

the eggs of intestinal helminthes (trichuris suis ova) administered as 2500 ova doses every two weeks.

Intervention: Drug: Trichuris Suis Ova

Placebo Comparator: Placebo

placebo dosage received every two weeks.

Intervention: Drug: Trichuris Suis Ova

Publications *

Not Provided

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ICMJE

Unknown status

Estimated Enrollment ICMJE

10

Estimated Completion Date

July 2014

Estimated Primary Completion Date

June 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ICMJE

Inclusion Criteria:

Age 18-35, inclusive, at the time of consent

Outpatient

Meet criteria for the diagnosis of Autism Spectrum Disorder according to the DSM-IV-TR, and supported by the ADOS or ADI-R.

Have an IQ of 70 or greater

Participants who are taking other medications prior to enrollment must be on a stable dose of concomitant medication, including psychotropic, anticonvulsant, or sleep aid for at least 3 months prior to baseline ratings

Be judged reliable for medication compliance and agree to keep appointments for study contacts and tests as outlined in the protocol (both subjects and guardians)

Have a personal or family history of allergies.

Exclusion Criteria:

History of Bipolar disorder or Psychotic Disorders (e.g. schizophrenia or schizoaffective disorders).